NCT07795710

Brief Summary

intermittent bolus doses of phenylephrine, norepinephrine and ephedrine for the management of spinal induced hypotension in preeclamptic patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
Last Updated

August 31, 2026

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

August 11, 2026

Last Update Submit

August 27, 2026

Conditions

EphedrineNorepinephrine

Keywords

preeclamptic patientsspinal induced hypotensionnorepinephrineephedrine

Outcome Measures

Primary Outcomes (1)

  • Heart rate changes

    every 3 minutes till 40 minutes

Secondary Outcomes (1)

  • Systolic blood pressure

    every 3 minutes till 40 minutes

Study Arms (3)

Group 1 (phenyelepherine group)

EXPERIMENTAL

receive bolus dose of phenyelepherine 75 ug

Drug: Group 1 (P)

Group 2 ( noradrenaline group)

EXPERIMENTAL

receive bolus dose of noradrenaline 4 ug

Drug: Group 2( N)

Group 3 ( ephedrine group)

EXPERIMENTAL

receive bolus dose ephedrine 4 mg

Drug: Group 3( E)

Interventions

Group 1 (P)DRUG

receive bolus dose of phenyelepherine 75 ug

Group 1 (phenyelepherine group)
Group 2( N)DRUG

Group 2( N) will receive bolus dose of noradrenaline 4 ug

Group 2 ( noradrenaline group)
Group 3( E)DRUG

Group 3( E) will receive bolus dose ephedrine 4 mg

Group 3 ( ephedrine group)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Preeclamptic pregnant female
  • ASA II and III
  • singleton or twin pregnancies will be scheduled for caesarean delivery
  • diagnosis of preeclampsia as a new onset of hypertension and proteinuria.

You may not qualify if:

  • chronic hypertension, labor or failed trial of labor,
  • body mass index ≥40 kg/m2 ,
  • resting heart rate \<60 bpm, eclampsia,
  • known fetal anomalies, contraindications to spinal anesthesia, abruption placentae, and cord prolapas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Egypt

Location

Study Officials

  • Ali Ali, Assistant lecturer

    Assistant lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 31, 2026

Study Start

January 30, 2024

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

August 31, 2026

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, ICF

Locations

EG(1)